The Correlation Between Filling Pressure, Cardiac Output and Plasma Copeptin in Patients With Systolic Heart Failure

Heart Failure Clinical Trial

Official title:

The Correlation Between Filling Pressure, Cardiac Output and Plasma Copeptin in Patients With Systolic Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01748006
• Other study ID #: H-1-2012-019
• Status: Recruiting
• Phase: Phase 0
• First received: August 15, 2012
• Last updated: October 26, 2015
• Start date: June 2012
• Est. completion date: June 2016

Study information

• Verified date: October 2015
• Source: Rigshospitalet, Denmark
• Contact: Finn Gustafsson, MD, DMSc
• Phone: 004535459743
• Email: finng[@]dadlnet.dk
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial Summary

The relationship between the activation of the vasopressin system and central hemodynamics in heart failure (including right and left heart filling pressures and cardiac output) is not clear. The investigators intend to examine the correlation between levels of copeptin and vasopressin and the central hemodynamic system in patients with advanced (class III or IV) heart failure. The investigators also aim to examine the relationship of selected cardiac biomarkers in blood and urine with cardiac filling pressures and cardiac output in patients with decompensated heart failure.

The study population will consist of 30 patients admitted to the Department of Cardiology at Copenhagen University Hospital. Only patients for whom the attending cardiologist has already decided upon right heart catheterization for clinical/treatment reasons will be recruited for the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age > 18 years

2. Left ventricular ejection fraction < 40 %

3. Diagnosed symptomatic heart failure treated with heart failure medications for at least 30 days.

4. Clinical indication for right heart catheterization for clinical/treatment reasons

5. NYHA-class III-IV

6. Relevant heart failure treatment as tolerated by the patient

Exclusion Criteria:

1. Absence of clinical/treatment indication of right heart catheterization

2. Syndrome of Inappropriate Secretion of ADH (SIADH)

3. Recent acute myocardial infarction within the last 30 days

4. Presence of infection or inflammatory disease

5. Malignant disease

6. Pregnancy

7. Subjects unwilling or unable to provide written consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic

Intervention

Other:
• Standard of care therapy for severe decompensated heart failure

Locations

Country	Name	City	State
Denmark	Department of Cardiology, Copenhagen University Hospital, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Finn Gustafsson

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The correlation between levels of plasma copeptin and vasopressin with left ventricular filling pressure and cardiac output		Day 1	No
Secondary	The correlation between levels of plasma copeptin and vasopressin with urine aquaporin-2 concentration		Day 1	No
Secondary	The correlation between New York Heart Association (NYHA) class and levels of plasma copeptin and vasopressin		Day 1	No
Secondary	The correlation between biomarkers levels and survival free of transplantation- and left ventricular assist device insertion		1 year	No